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Ambien (Zolpidem) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ambien (Zolpidem) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (302)
Death (46)
Life Threatening Events (24)
Disability (5)

Reports by Reaction Type

Drug Ineffective (36)Insomnia (35)Somnambulism (26)Road Traffic Accident (23)Suicide Attempt (21)Pain (20)Completed Suicide (20)Intentional Overdose (17)Somnolence (17)Stress (17)Fall (16)Depression (16)

Below are a few examples of reports where side effects / adverse reactions may be related to Ambien (Zolpidem). For a complete list or a specific selection of reports, please use the links above.

Possible Ambien side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Vomiting, Systemic Lupus Erythematosus, Drug Hypersensitivity, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-05-23

Nuvaring
    Dosage: unk
    Indication: Contraception
    Start date: 2009-01-01
    End date: 2009-05-24

Other drugs received by patient: Lexapro



Possible Ambien side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Radial Nerve Palsy, Arthralgia, Wrist Fracture

Drug(s) suspected as cause:
Ambien



Possible Ambien side effects in 26 year old female

Reported by a lawyer from United States on 2012-08-23

Patient: 26 year old female, weighing 128.0 kg (281.6 pounds)

Reactions: Weight Decreased, Depression, Stress

Drug(s) suspected as cause:
Albuterol
    Dosage: 3 ml, unk
    Indication: Asthma

Ambien
    Dosage: 10 mg, unk
    Indication: Product Used FOR Unknown Indication

Axotal
    Indication: Product Used FOR Unknown Indication

Compazine
    Indication: Nausea

Compazine
    Dosage: 10 mg, unk
    Indication: Vomiting

Excedrin (Migraine)
    Indication: Headache

Ibuprofen
    Indication: Headache
    Start date: 2008-06-09

Lyrica
    Indication: Product Used FOR Unknown Indication

Symbicort
    Dosage: 80 mg, 2x/day
    Indication: Asthma

Tessalon
    Administration route: Oral
    Indication: Cough

Topamax
    Dosage: 100 mg, 2x/day
    Administration route: Oral
    Indication: Migraine
    Start date: 2006-01-01

Tylenol W / Codeine
    Administration route: Oral
    Indication: Headache

Zofran
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Multi-Vitamins; Iron



Possible Ambien side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 66.0 kg (145.2 pounds)

Reactions: Confusional State, Blood Bilirubin Increased, Pulmonary Embolism, Failure To Thrive, Rash Pruritic, Hypokalaemia, Fatigue, Hypomagnesaemia, Oedema Peripheral, Hypocalcaemia, Pneumopericardium, Decreased Appetite, Metabolic Acidosis, Nausea, Hypotension, Rash Papular, Hyperglycaemia, Blood Lactic Acid Increased, Respiratory Failure, Insomnia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ambien
    Dosage: unk
    Indication: Insomnia

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-07
    End date: 2012-07-12

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    End date: 2012-08-01

Mk2206
    Dosage: 135 mg, weekly
    Administration route: Oral
    End date: 2012-06-26

Mk2206
    Dosage: 135 mg, weekly
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-07
    End date: 2012-07-12

Other drugs received by patient: Fluticasone Propionate / Salmeterol; Cymbalta; Oxycodone HCL; Oxycontin; Spiriva; Prevacid; Magnesium



Possible Ambien side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 86 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Drug Ineffective, Insomnia, Drug Administration Error

Drug(s) suspected as cause:
Advil
    Dosage: 600 mg (three capsules of 200mg), as needed
    Administration route: Oral
    Start date: 2012-01-01

Advil
    Dosage: unk, as needed
    Administration route: Oral
    Indication: Arthralgia
    End date: 2012-01-01

Ambien
    Dosage: 10 mg, daily
    Indication: Insomnia
    Start date: 2012-08-12
    End date: 2012-08-15

Other drugs received by patient: Cozaar; Synthroid; Clonidine; Norvasc



Possible Ambien side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Weight Decreased, Maternal Exposure During Pregnancy, Depression, Stress

Drug(s) suspected as cause:
Albuterol
    Indication: Asthma

Ambien
    Indication: Product Used FOR Unknown Indication

Butalbital Acetaminophen and Caffeine
    Indication: Product Used FOR Unknown Indication

Compazine
    Indication: Nausea

Compazine
    Indication: Vomiting

Excedrin (Migraine)
    Indication: Headache

Ibuprofen
    Indication: Headache
    Start date: 2008-06-09

Lyrica
    Indication: Product Used FOR Unknown Indication

Symbicort
    Dosage: 2 puffs twice daily.
    Indication: Asthma

Tessalon
    Administration route: Oral
    Indication: Cough

Topamax
    Administration route: Oral
    Indication: Migraine
    Start date: 2006-01-01

Tylenol W / Codeine
    Administration route: Oral
    Indication: Headache

Zofran
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Multi-Vitamins; Repliva



Possible Ambien side effects in 72 year old female

Reported by a physician from United States on 2012-08-21

Patient: 72 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Confusional State, Blood Bilirubin Increased, Atelectasis, Blood Albumin Decreased, Pulmonary Embolism, Failure To Thrive, Hypokalaemia, Rash Pruritic, Fatigue, Glycosylated Haemoglobin Increased, Hypomagnesaemia, Chest Pain, Oedema Peripheral, Hypocalcaemia, Pleural Effusion, Pneumopericardium, Decreased Appetite, Dyspnoea, Metabolic Acidosis, Blood Chloride Decreased, Nausea, Hypotension, Hyperglycaemia, Blood Lactic Acid Increased, Heart Rate Decreased, Respiratory Failure, Carbon Dioxide Decreased, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Ambien
    Indication: Insomnia

Antineoplastic Agents
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-07
    End date: 2012-07-12

Antineoplastic Agents
    Administration route: Oral
    End date: 2012-07-26

Tarceva
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-07
    End date: 2012-07-12

Tarceva
    Administration route: Oral
    End date: 2012-08-01

Other drugs received by patient: Magnesium; Spiriva; Prevacid; Cymbalta; Oxycodone HCL; Oxycontin; Advair



Possible Ambien side effects in 56 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 56 year old male, weighing 108.9 kg (239.5 pounds)

Reactions: Peripheral Coldness, Blood Pressure Increased, Vomiting, Muscular Weakness, Headache, Anxiety, Incontinence, DRY Mouth, Chest Pain, Heart Rate Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien
    Dosage: one at nigh po
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-08-10
    End date: 2012-08-15

Ambien
    Dosage: one at nigh po
    Administration route: Oral
    Indication: Pain
    Start date: 2012-08-10
    End date: 2012-08-15

Ambien CR
    Dosage: one at night po
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-05-27
    End date: 2012-06-27

Ambien CR
    Dosage: one at night po
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-27
    End date: 2012-06-27



Possible Ambien side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Anxiety, Pneumonia Aspiration, Sleep Apnoea Syndrome

Drug(s) suspected as cause:
Ambien

Other drugs received by patient: Atenolol; Simvastatin; Multaq; Coumadin



Possible Ambien side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male

Reactions: Anxiety, Plasmacytoma, Haemoptysis, Insomnia, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien
    Administration route: Oral

Dianeal
    Indication: Peritoneal Dialysis

Extraneal
    Indication: Peritoneal Dialysis



Possible Ambien side effects in female

Reported by a lawyer from United States on 2012-08-08

Patient: female

Reactions: Weight Decreased, Maternal Exposure During Pregnancy, Depression, Stress

Drug(s) suspected as cause:
Albuterol
    Indication: Asthma

Ambien
    Indication: Product Used FOR Unknown Indication

Butalbital Acetaminophen and Caffeine
    Indication: Product Used FOR Unknown Indication

Compazine
    Indication: Nausea

Compazine
    Indication: Vomiting

Excedrin (Migraine)
    Indication: Headache

Ibuprofen
    Indication: Headache
    Start date: 2008-06-09

Lyrica
    Indication: Product Used FOR Unknown Indication

Symbicort
    Dosage: 2 puffs twice daily.
    Indication: Asthma

Tessalon
    Administration route: Oral
    Indication: Cough

Topamax
    Administration route: Oral
    Indication: Migraine
    Start date: 2006-01-01

Tylenol W / Codeine
    Administration route: Oral
    Indication: Headache

Zofran
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Multi-Vitamins; Repliva



Possible Ambien side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient: female, weighing 66.0 kg (145.2 pounds)

Reactions: Confusional State, Blood Bilirubin Increased, Pulmonary Embolism, Failure To Thrive, Rash Pruritic, Hypokalaemia, Fatigue, Hypomagnesaemia, Oedema Peripheral, Hypocalcaemia, Decreased Appetite, Pneumopericardium, Metabolic Acidosis, Nausea, Hypotension, Rash Papular, Hyperglycaemia, Blood Lactic Acid Increased, Respiratory Failure, Insomnia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ambien
    Dosage: unk
    Indication: Insomnia

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    End date: 2012-08-01

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-07
    End date: 2012-07-12

Mk2206
    Dosage: 135 mg, weekly
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-07
    End date: 2012-07-12

Mk2206
    Dosage: 135 mg, weekly
    Administration route: Oral
    End date: 2012-06-26

Other drugs received by patient: Fluticasone Propionate; Oxycontin; Prevacid; Magnesium; Oxycodone HCL; Cymbalta; Spiriva



Possible Ambien side effects in 56 year old male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 56 year old male, weighing 76.0 kg (167.2 pounds)

Reactions: Agitation, Anxiety, Completed Suicide, Insomnia, Stress, Verbal Abuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Ambien
    Administration route: Oral
    Start date: 2010-03-04

Ambien
    Administration route: Oral
    Start date: 2006-04-02

Other drugs received by patient: Lexapro; Xanax; Aspirin; Vitamin TAB; Ibuprofen



Possible Ambien side effects in 22 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 22 year old female

Reactions: Vomiting, Nausea

Drug(s) suspected as cause:
Ambien
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-07-30

Pristiq
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-07-30

Pristiq
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Depression

Pristiq
    Indication: Bipolar Disorder

Trileptal
    Dosage: unk
    Indication: Bipolar Disorder
    Start date: 2012-07-30



Possible Ambien side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 65 year old female, weighing 68.5 kg (150.7 pounds)

Reactions: Victim of Abuse, Contusion, Legal Problem, Hepatitis C, Maternal Exposure During Pregnancy, Retinal Vein Occlusion, Fall, Rheumatoid Arthritis, Post-Traumatic Stress Disorder, Caesarean Section, Neuropathy Peripheral, Balance Disorder, Blindness Unilateral, Cryoglobulinaemia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Ambien
    Dosage: 10 mg;hs
    Indication: Insomnia
    Start date: 2012-07-01
    End date: 2012-07-01

Methadone HCL
    Indication: Pain

Restoril
    Dosage: 15 mg; 30 mg
    Indication: Insomnia
    Start date: 2012-01-01
    End date: 2012-01-01

Restoril
    Dosage: 15 mg; 30 mg
    Indication: Insomnia
    Start date: 2012-01-01
    End date: 2012-01-01

Seconal Sodium
    Dosage: 1 capsule;qod
    Indication: Insomnia
    Start date: 1967-01-01
    End date: 1973-01-01



Possible Ambien side effects in 53 year old female

Reported by a lawyer from United States on 2012-08-06

Patient: 53 year old female

Reactions: Psychomotor Hyperactivity, Bipolar I Disorder, Abnormal Behaviour

Drug(s) suspected as cause:
Ambien

Other drugs received by patient: Pramipexole Dihychloride; Trazodone Hydrochloride; Acetaminophen and Tramadol HCL; Valsartan; Clonazepam



Possible Ambien side effects in 57 year old female

Reported by a physician from United States on 2012-08-06

Patient: 57 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Alcohol
    Dosage: unk

Ambien
    Dosage: unk

Caffeine Citrate
    Dosage: unk

Ceclor
    Dosage: unk

Ceftin
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Cleocin Hydrochloride
    Dosage: unk

Compazine
    Dosage: unk

Duricef
    Dosage: unk

Epinephrine
    Dosage: unk

Gadolinium
    Dosage: unk

Heparin
    Dosage: unk

Indocin
    Dosage: unk

Iodine
    Dosage: unk

Monistat
    Dosage: unk

Mycelex
    Dosage: unk

Nizoral
    Dosage: unk

Oxymetazoline HCL
    Dosage: unk

Relafen
    Dosage: unk



Possible Ambien side effects in 39 year old male

Reported by a lawyer from United States on 2012-08-06

Patient: 39 year old male

Reactions: Disturbance in Attention, GUN Shot Wound, Somnambulism

Adverse event resulted in: death

Drug(s) suspected as cause:
Ambien



Possible Ambien side effects in 33 year old male

Reported by a lawyer from United States on 2012-08-06

Patient: 33 year old male

Reactions: Affective Disorder, Suicide Attempt, Amnesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien
    Indication: Insomnia

Cimetidine



Possible Ambien side effects in 56 year old male

Reported by a lawyer from United States on 2012-08-03

Patient: 56 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Ambien



Possible Ambien side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 61 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Vomiting, Nausea, Drug Effect Increased, Sedation, Lethargy

Drug(s) suspected as cause:
Ambien
    Administration route: Oral
    Indication: Insomnia

Fentanyl
    Dosage: q72h
    Start date: 2012-07-01

Fentanyl
    Dosage: q72h
    Indication: Back Pain
    Start date: 2012-05-14
    End date: 2012-07-04

Other drugs received by patient: Meloxicam; Protonix; Estradiol; Zyrtec; Lipitor; Synthroid



Possible Ambien side effects in 38 year old male

Reported by a lawyer from United States on 2012-08-03

Patient: 38 year old male

Reactions: Agitation, Completed Suicide

Drug(s) suspected as cause:
Ambien

Other drugs received by patient: Metoclopramide



Possible Ambien side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 52 year old female

Reactions: Speech Disorder, Road Traffic Accident, Dizziness, Disorientation, Amnesia

Drug(s) suspected as cause:
Ambien

Other drugs received by patient: Synthroid



Possible Ambien side effects in 28 year old female

Reported by a physician from United States on 2012-08-02

Patient: 28 year old female

Reactions: Petit MAL Epilepsy, Drug Abuse, Drug Dependence, Convulsion

Drug(s) suspected as cause:
Ambien
    Start date: 2012-01-01

Ambien
    Start date: 2012-01-01



Possible Ambien side effects in 30 year old female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: 30 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Incorrect Dose Administered, Suicide Attempt, Drug Administration Error, Drug Dependence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien



Possible Ambien side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: female, weighing 68.2 kg (150.0 pounds)

Reactions: Drug Ineffective, Pain, Stress, Eye Pain, Weight Increased, Gastrointestinal Disorder, Irritable Bowel Syndrome, Blood Glucose Fluctuation, DRY Eye

Drug(s) suspected as cause:
Ambien
    Administration route: Oral
    Indication: Sleep Disorder

Imitrex
    Administration route: Oral
    Indication: Headache

Piroxicam

Xanax
    Dosage: 2mg per day
    Administration route: Oral
    Indication: Insomnia

Other drugs received by patient: Dihydroergotamine Mesylate; Vitamin D; Carisoprodol



Possible Ambien side effects in male

Reported by a physician from United States on 2012-07-27

Patient: male

Reactions: Refusal of Treatment by Patient, Nightmare, Psychotic Disorder

Drug(s) suspected as cause:
Ambien
    Administration route: Oral
    Indication: Bipolar I Disorder
    Start date: 2012-02-01

Ambien
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-02-01

Ambien
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2012-02-01

Invega Sustenna
    Start date: 2012-02-06
    End date: 2012-02-06

Invega Sustenna
    End date: 2012-02-01

Invega Sustenna
    End date: 2012-02-01

Invega Sustenna
    End date: 2012-02-01

Invega Sustenna
    Indication: Bipolar I Disorder
    Start date: 2012-02-06
    End date: 2012-02-06

Invega Sustenna
    Indication: Schizophrenia
    Start date: 2012-02-06
    End date: 2012-02-06

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    End date: 2012-02-01



Possible Ambien side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 39 year old female, weighing 79.4 kg (174.7 pounds)

Reactions: Malaise, Drug Ineffective, Insomnia, Intentional Drug Misuse

Drug(s) suspected as cause:
Ambien

Lunesta

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel
    Administration route: Oral
    Indication: Depression

Other drugs received by patient: Other Prescription; Other Prescription



Possible Ambien side effects in 33 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 33 year old female

Reactions: Drug Dose Omission, Insomnia, Somnolence

Drug(s) suspected as cause:
Ambien

Seroquel XR
    Administration route: Oral
    Indication: Schizophrenia

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel XR
    Administration route: Oral
    Indication: Anxiety

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Bipolar I Disorder

Seroquel XR
    Administration route: Oral



Possible Ambien side effects in 53 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-27

Patient: 53 year old female, weighing 82.6 kg (181.7 pounds)

Reactions: Tachyphrenia, Insomnia

Drug(s) suspected as cause:
Ambien

Celexa
    Dosage: 10-15 mg, qam

Lithium Carbonate
    Administration route: Oral

Lithium Carbonate
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar II Disorder
    Start date: 2011-12-20
    End date: 2012-03-03

Trazodone Hydrochloride

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